DEFERASIROX TARO 500 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

DEFERASIROX

Commercializzato da:

TARO INTERNATIONAL LTD, ISRAEL

Codice ATC:

V03AC03

Forma farmaceutica:

DISPERSIBLE TABLETS FOR ORAL SUSPENSION

Composizione:

DEFERASIROX 500 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

SUN PHARMACEUTICAL INDUSTRIES LTD, INDIA

Area terapeutica:

DEFERASIROX

Indicazioni terapeutiche:

Deferasirox Taro is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adult and pediatric patients (aged 2 years and over). Deferasirox Taro is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older. Chelation therapy should only be initiated when there is evidence of iron overload (liver iron concentration [LIC]≥5 mg Fe/g dry weight [dw] or serum ferritin consistently >800 μg/l). LIC is the preferred method of iron overload determination and should be used wherever available.

Data dell'autorizzazione:

2022-12-22

Foglio illustrativo

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
The medicine is dispensed with a doctor’s prescription only
DEFERASIROX TARO
®
125 mg
Dispersible tablets for
oral suspension
DEFERASIROX TARO
®
250 mg
Dispersible tablets for
oral suspension
DEFERASIROX TARO
®
500 mg
Dispersible tablets for
oral suspension
Each dispersible tablet
contains:
deferasirox 125 mg
Each dispersible tablet
contains:
deferasirox 250 mg
Each dispersible tablet
contains:
deferasirox 500 mg
Inactive ingredients and allergens in this medicine: see section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional
information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your or your child's
illness. Do not pass it
on to others. It may harm them, even if it seems to you that their
illness is similar to
yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
To treat chronic iron overload caused by blood
transfusions(transfusional
hemosiderosis) in adults and children (aged 2 years and older).
•
To treat chronic iron overload in patients with non-transfusion-
dependent
thalassemia aged 10 years and older.
Therapeutic group: iron chelating agent.
Repeated blood transfusions are sometimes necessary in patients
suffering from
certain types of anemia such as thalassemia, sickle-cell disease and
myelodysplastic
syndromes (MDS). However, repeated blood transfusions may cause a
build-up of
excess iron. This is because blood contains iron and the body does not
have a
natural way to remove the excess iron received with the blood
transfusions. In
patients with non-transfusion-dependent thalassemia, iron overload may
develop
over time, mainly due to increased absorption of dietary iron in
response to low blood
cell counts. Over time, the excess iron can damage vital org